Full Text PA-95-022

DRUG ABUSE HEALTH SERVICES RESEARCH AND HIV/AIDS

NIH GUIDE, Volume 24, Number 2, January 20, 1995

PA NUMBER:  PA-95-022

P.T.


Keywords: 


National Institute on Drug Abuse

PURPOSE

This Program Announcement will support a program of research on
health services to drug abusers at high risk for HIV/AIDS at the
client, program, and service system level.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of Healthy People 2000, a
PHS-led national activity for setting priority areas.  This PA, Drug
Abuse Health Services Research, is related to the priority area of
alcohol and other drugs.  Potential applicants may obtain a copy of
Healthy People 2000 (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by for-profit and non-profit, public
and private organizations such as universities, colleges, hospitals,
units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as principal
investigators.  Foreign institutions are not eligible for First
Independent Research Support and Transition (FIRST) Awards (R29).

MECHANISM OF SUPPORT

This program announcement will use the National Institutes of Health
(NIH) individual research grant (R01), interactive research project
grant (IRPG), small grant (R03), and FIRST award (R29).  For further
information on the IRPG mechanism refer to PA-94-086, NIH Guide for
Grants and Contracts, Vol. 24, No. 28, July 29, 1994.  Responsibility
for the planning, direction, and execution of the proposed project
will be solely that of the applicant.

RESEARCH OBJECTIVES

Organizations providing drug abuse services have undergone rapid and
complex changes over the past decade, both in response to the AIDS
epidemic and larger changes in health care in the United States.  The
range of drug abuse services has expanded with the identification of
drug-related problems (e.g., HIV infection, psychiatric co-morbidity,
complications of pregnancy) and growing needs to intervene earlier
and in a variety of settings.  At the same time, the available drug
abuse treatment modalities have evolved in the direction of becoming
more diversified, providing a wider range of services, and forming
linkages with the traditional health care establishment.  In
addition, new modalities and patterns of ownership (e.g., private,
chemical dependency programs) and financial status (for-profit and
not-for-profit) have emerged and thus a "two tier" system has
resulted.

More than one-third of the cases of AIDS have resulted from behaviors
associated with drug abuse, such as needle sharing, drug-related
prostitution, and sexual contact with infected drug abusers.  There
is a pressing need, therefore, to prevent the transmission of HIV in
drug-related populations, provide accessible and appropriate services
to infected drug abusers, and better understand how the service
system can meet more of the needs of at-risk and infected
populations.  Achieving these goals is made more difficult, however,
by formidable obstacles, that include gaps in services financing;
fragmentation of services; limitations on eligibility, access, and
utilization; the chronicity of drug abuse and dependence; and the
reluctance of many drug abusers to enter treatment.

Inducing behavior change, which is the only strategy currently
available to prevent HIV infection among drug abusers, is a central
goal of drug abuse treatment, as well as interventions outside
treatment settings.  NIDA's community-based research indicates that a
large percentage of injecting drug users have never enrolled in drug
abuse treatment programs.  For many drug abusers, primary and
critical care (including emergency room episodes, and primary care
contacts within the criminal justice system) is their only contact
with health care providers.  Thus, a comprehensive approach to
preventing transmission of HIV infection must include intervention in
a variety of settings, including primary care, the community at
large, and in drug abuse treatment programs and systems.

This Program Announcement invites applications to study how drug
abuse and other health services and service systems affect the
prevention and management of HIV/AIDS in drug-abusing populations.
Of special interest to NIDA are applications that focus on how the
financing, organization, and management of drug abuse services affect
access to and utilization, cost, quality, and outcomes of those
services for high-risk or HIV-infected persons.  High-risk persons
include those whose drug abuse (especially intravenous use and the
sharing of syringes) or drug-related sexual behaviors (including
prostitution and other sex-for-drug exchanges) increase their risk of
becoming infected or infecting others.  Health services research
proposals may include studies of systems, programs, or clients.  They
may address risk-reduction interventions in primary care settings or
in drug abuse treatment programs.  They may also focus on linkages
between primary care and drug abuse treatment and on the delivery of
services in non-traditional or community settings.  In addition,
applications may include studies of the role of services in reducing
or preventing the transmission of HIV infection from drug abusers to
sexual partners, or to the infants of drug abusers.

Service and client outcome measures must include those relevant to
HIV behavioral risk factors (such as needle sharing and unprotected
sex), and to the utilization of HIV and AIDS services, such as AIDS
counseling.  Service system research may address the financing,
organization, management, access and utilization of drug abuse
treatment and other AIDS-related services, the integration of HIV
risk reduction strategies into programs and systems of care utilized
by drug abusers, and the cost-effectiveness and cost-offsets of HIV
prevention efforts provided by drug abuse treatment and other
interventions. Research is also needed on the need, demand,
utilization, effectiveness, and cost-effectiveness of HIV outreach
and prevention efforts with specific subgroups in various settings.

Research applications are encouraged in four major areas of health
services research:

(1) drug abuse treatment services focused at system, program, and or
client level; (2) HIV prevention services for drug abusers and their
sexual partners, in health care settings and elsewhere; (3) health
services for high-risk drug abusers in primary care settings,
including closer linkages between primary care and drug abuse
treatment programs; and (4) service needs, access, and utilization by
adolescents, minority cultures, women of childbearing age and their
young children, and high-risk "bridge" populations, such as gay
intravenous drug abusers and drug abusers engaged in prostitution.
Research proposals that focus on research within these areas or that
cut across areas are encouraged.  Topics not mentioned are not
necessarily excluded from consideration under this Program
Announcement.

Studies are encouraged on the following kinds of issues:

o  The effects of various financing strategies on access to and the
costs, quality, and outcomes of care for high-risk drug abusers
(e.g., effects of private insurance coverage, Medicaid waivers, block
grants, fixed budgets, and various cost and utilization controls as a
part of financing programs, as in managed care);

o  How various forms of long-term care (such as residential care and
less intensive forms of stretched-out care) affect utilization of
services, retention in services, relapse rates, costs, and long- term
recovery processes for high-risk clients;

o  How client and program factors influence treatment-seeking
behavior, costs, utilization, quality, effectiveness, relapse, and
changes in AIDS risk behaviors;

o  Organization and management of specialized services to meet the
multiple needs of HIV-positive drug abusers and to reduce the spread
of infection;

o  Access, delivery, integration, and management of HIV prevention
interventions to individuals both in and out of drug abuse treatment,
including delivery to specific high-risk subgroups such as
adolescents, sexual partners of HIV positives, those in the criminal
justice system, and those with chronic medical or psychiatric
problems;

o  Barriers to service access and utilization for specific high-risk
client populations and HIV-positive clients, and strategies for
overcoming these barriers;

o  Impact of specific cost and utilization control policies and
strategies on outreach, service delivery, retention in care, and
effectiveness for clients at differing levels of HIV risk;

o  How various models of case management can improve the continuity
and integration of care, and control of costs;

o  Making HIV outreach and prevention services more effective and
cost-effective for reducing risk behaviors;

o  Patterns of staffing, background, training, and experience of
providers and AIDS outreach programs, in relation to service needs of
high-risk clients;

o  Design, organization, and management of accessible and effective
combinations of drug abuse and primary care services;

o  Service system models to improve the quality and effectiveness of
drug abuse treatment services, including matching, referral, and
other linkage processes;

o  Improvement of linkages and liaisons with external resources,
including improvements in the management of information and access to
service networks;

o  The impact of improved record keeping (e.g., via longitudinal
records and improved exchange of client records among primary care
and other practitioners) and confidentiality safeguards on the
continuity, adequacy, appropriateness, quality, and outcomes of care;

o  How health care and other organizations receive, assimilate, and
adopt or respond to knowledge about the treatment of high-risk drug
abusers;

o  Development of alternative HIV antibody testing and reporting
strategies to improve access and utilization of appropriate services;

o  Organization, financing, utilization, and delivery of effective
cross-training for primary care providers and drug abuse treatment
providers;

o  How identification of drug abuse and associated HIV risk factors
and complications can be improved, in non-drug abuse treatment
settings, such as sexually transmitted disease clinics or educational
settings;

o  How client and patient engagement in and compliance with medical
treatment programs and referrals can enhanced.

o  Methods for diffusing innovative clinical practices and management
techniques to improve drug abuse treatment and other HIV prevention
services, and to lower costs; and

o  New methodologies (in measurement, research designs, and analytic
techniques) that hold promise for the study of HIV-related aspects of
drug abuse services, including valid and reliable measures of high-
risk behaviors, behavior change, and client needs.

Applicants are advised to review existing information relevant to
drug abuse health services research and to design studies using the
most rigorous methodological and analytic designs feasible.  Timely
reporting of findings is emphasized.  Applicants should be willing to
participate in research coordination efforts to maximize the utility
of the research, including review and dissemination activities.

Where appropriate, investigators are encouraged to offer HIV testing
and counseling in accordance with current guidelines to subjects
identified during the course of the research as being at risk for HIV
acquisition or transmission.  In high risk populations, investigators
are encouraged to assess the effects of new interventions on the
acquisition and transmission of infectious diseases, including HIV.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990. The new policy contains some new
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard application
deadlines as indicated in the application kit.  The receipt dates for
applications for AIDS-related research are found in the PHS 398
instructions.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Office of
Grants Information, Division of Research Grants, NIH, Westwood
Building, Room 449, Bethesda, MD 20892, telephone 301-710-0267.  The
title and number of this program announcement must be typed in Item
2a on the face page of the application.

FIRST applications must include at least three sealed letters of
reference attached to the face page of the original application.
FIRST applications submitted without the required number of reference
letters will be considered incomplete and will be returned without
review.

The completed original and five permanent, legible copies of the PHS
398 form must be delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit by study sections of NIH in accordance with the
standard NIH peer review procedures.  Following scientific-technical
review, the applications will receive a second-level review by the
appropriate advisory council.  Small grant applications do not
receive a second level review.

As part of the initial merit review, triage will be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the program
announcement.  Applications judged to be non- competitive will be
withdrawn from further consideration and the Principal Investigator
and the official signing for the applicant organization will be
notified.

Review Criteria

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the
protection of human and animals subjects, and the safety of the
research environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:  quality of the proposed project as determined by peer
review; availability of funds; adequacy of provisions for the
protection of human subjects; and program priority.

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Frank M. Tims, Ph.D.
Services Research Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-30
Rockville, MD  20857
Telephone:  (301) 443-4060
Email:  FTIMS@AOADA.SSW.DHHS.GOV

Direct inquiries regarding fiscal matters to:

Gary Fleming
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  GFLEMING@AOADA.SSW.DHHS.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under authorization of the
Public Health Service Act, Section 301, and administered under PHS
policies and Federal Regulations at Title 42 CFR 52 "Grants for
Research Projects", Title 45 CFR Part 74 & 92, "Administration of
Grants" and 45 CFR Part 46, "Protection of Human Subjects". Title 42
CFR  Part 2, "Confidentiality of Alcohol and Drug Abuse Patient
Records" may also be applicable to these awards.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

Sections of the Code of Federal Regulations are available in booklet
form from the U.S. Government Printing Office.  Grants must be
administered in accordance with the PHS Grants Policy Statement,
(rev. 4/94), which may be available from your office of sponsored
research.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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